D-1855-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 18, 2019
- Initiation Date
- September 3, 2019
- Termination Date
- March 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 4x5 ml, b) 1x10 ml bottles
Product Description
5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Reason for Recall
Lack of Processing Controls:
Distribution Pattern
Product was dispensed to patients
Code Information
Lots a) 07182019@29 exp: 8/31/19, 07082019@2 exp: 8/31/19, 06052019@21 exp:08/31/19 06062019@52 exp: 6/25/19; b) 07022019@28 exp: 8/31/19